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NCT04034251 · ClinicalTrials.gov registry record · Phase 2

Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

A Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
12
Enrollment target
1
Study location

NCT04034251 is a Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04034251, a Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

Background: Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow. Objective: To find a better way to treat advanced stomach cancer. Eligibility: People ages 18 and older with stomach cancer that has spread throughout their belly. Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Scans Cancer sample: If they do not have one, they will have a biopsy. Tests of performance of normal activities Dietary assessment Participants will have a laparoscopy. Small cuts are made into their abdomen. A thin camera with a light is inserted. Small instruments are used to take biopsies. This will be repeated during the study to monitor the cancer. During the first laparoscopy, a port with a catheter attached will be put into the abdomen. Participants may also have an endoscopy: A thin tube with a camera is inserted through the mouth and into the stomach. The tube collects samples to monitor the cancer. Participants will get paclitaxel every 3 weeks through the abdominal port and through a small plastic tube in an arm vein. They will also take capecitabine by mouth twice daily for the first 15 days of a 21-day cycle. After participants finish 3 cycles, they will have scans to see how they are doing. They may get another course of therapy. Participants will have visits every 3 weeks during treatment. Then they will have follow-up visits for 5 years. Then they will keep in touch with researchers for the rest of their life.

Interventions

  • DRUG Capecitabine
  • DRUG Paclitaxel
  • DEVICE BardPort Titanium Implanted Port with Peritoneal Catheter

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-06-09
Est. Completion 2024-09-05
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04034251

The ClinicalTrials.gov registry entry for NCT04034251 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (96% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.

NCT04034251 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04034251 about?

NCT04034251 is a clinical study titled "Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis". Background: Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow. Objective: To find a better way to treat advanced stomach cancer. Eligib...

What is the current status of trial NCT04034251?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2020-06-09. Estimated completion is 2024-09-05.

What conditions does trial NCT04034251 study?

This clinical trial studies the following conditions: Gastric Cancer, Gastric Adenocarcinoma, Peritoneal Carcinomatosis, Esophagogastric Junction.

What interventions are being tested in trial NCT04034251?

The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), BardPort Titanium Implanted Port with Peritoneal Catheter (DEVICE).

Who is sponsoring clinical trial NCT04034251?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04034251 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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